FDAClass IIJanuary 17, 2024

Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 recall

Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

Why was Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 recalled?

Surgical gowns were manufactured with the wrong sleeve.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.

Product
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
2,100 gowns
Distribution
Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.
Recall date
January 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls